140 Participants Needed

Hyperpolarized MRI for Brain Tumor

JR
SC
WM
Overseen ByWendy Ma
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Susan Chang
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What data supports the effectiveness of the treatment Hyperpolarized Carbon C 13 Pyruvate for brain tumors?

Research shows that hyperpolarized Carbon C 13 Pyruvate can help detect treatment responses in brain tumors by tracking changes in tumor metabolism, which is useful for early identification of treatment effectiveness. This method has been effective in other cancers, like breast cancer, by providing detailed metabolic information that can guide treatment decisions.12345

Is hyperpolarized MRI using carbon-13 pyruvate safe for humans?

Research indicates that hyperpolarized carbon-13 pyruvate MRI has been safely used in humans, including healthy volunteers and pediatric patients with brain tumors, without reported adverse effects.12678

How does the treatment Hyperpolarized MRI for Brain Tumor differ from other treatments for this condition?

Hyperpolarized MRI for brain tumors is unique because it uses a special form of MRI with hyperpolarized carbon-13 pyruvate to visualize and measure the metabolism of brain tumors in real-time. This method provides detailed metabolic information that can help assess tumor activity and response to treatment, which is not possible with standard imaging techniques.124910

What is the purpose of this trial?

This pilot trial studies the side effects of hyperpolarized carbon C 13 pyruvate magnetic resonance imaging (MRI) in diagnosing participants with glioma. Diagnostic procedures, such as hyperpolarized carbon C 13 pyruvate MRI, may help find and diagnose glioma.

Research Team

Susan Chang | UCSF Brain Tumor Center

Susan Chang, MD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

This trial is for adults over 18 with a life expectancy of more than 12 weeks and diagnosed with glioma, who are not HIV-positive, pregnant or breastfeeding. Participants must have adequate kidney function, no severe heart failure or recent heart attacks, and no other cancers except certain skin cancers or cervical carcinoma in-situ unless in remission for at least 3 years.

Inclusion Criteria

I am over 18 years old and expected to live more than 12 weeks.
Patients must sign an informed consent indicating that they are aware of the investigational nature of this study. Patients must sign an authorization for the release of their protected health information.
I don't have any severe illnesses that would interfere with the study's imaging tests.
See 10 more

Exclusion Criteria

Subjects must be excluded from participating in this study if they are not able to comply with study and/or follow-up procedures.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging and Injection

Participants receive one or two hyperpolarized carbon C 13 pyruvate injections intravenously and undergo MRI

1 day
1 visit (in-person)

Treatment

Participants in Cohort II receive standard radiation and temozolomide treatment outside of this study

Varies based on standard treatment protocols

Post-Treatment Imaging

Participants in Cohort II undergo MRI 4 weeks after completion of cancer therapy

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 24 months

Treatment Details

Interventions

  • Hyperpolarized Carbon C 13 Pyruvate
  • Magnetic Resonance Imaging
Trial Overview The trial tests the safety of using hyperpolarized carbon C 13 pyruvate MRI to diagnose gliomas. It involves patients already scheduled for standard treatment with radiation and temozolomide (Cohort 2), as well as those with evaluable disease based on prior MR scans (Cohort 1).
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Cohort II (Hyperpolarized C13, MRI)Experimental Treatment4 Interventions
Participants receive hyperpolarized carbon C 13 pyruvate IV and undergo MRI before treatment and 4 weeks after completion of cancer therapy given outside of this study.
Group II: Cohort I (Hyperpolarized C13, MRI)Experimental Treatment2 Interventions
Participants receive hyperpolarized carbon C 13 pyruvate intravenously IV and undergo MRI. The second hyperpolarized 13 C injection/imaging will be started approximately 15 to 60 minutes after the first injection for those who are willing to receive two 13 C injections

Find a Clinic Near You

Who Is Running the Clinical Trial?

Susan Chang

Lead Sponsor

Trials
5
Recruited
520+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Findings from Research

Hyperpolarized [1-(13)C]pyruvate can effectively detect treatment responses in glioma tumors, which is challenging with traditional imaging methods like PET due to interference from normal brain tissue signals.
In a rat model, significant lactate labeling was observed in glioma tumors after treatment, with a notable decrease in the ratio of tumor lactate to blood pyruvate signal following whole brain irradiation, indicating a potential response to therapy.
Detecting response of rat C6 glioma tumors to radiotherapy using hyperpolarized [1- 13C]pyruvate and 13C magnetic resonance spectroscopic imaging.Day, SE., Kettunen, MI., Cherukuri, MK., et al.[2021]
This study is the first to use hyperpolarized 13C MRI to visualize and measure how the human brain processes [2-13C]pyruvate, providing insights into cerebral energy metabolism.
In a trial involving 5 healthy volunteers, the technique allowed for the simultaneous assessment of glycolytic and oxidative metabolism by quantifying the conversion rates of pyruvate to lactate and glutamate, highlighting its potential for advanced metabolic imaging.
Hyperpolarized [2-13C]pyruvate MR molecular imaging with whole brain coverage.Chung, BT., Kim, Y., Gordon, JW., et al.[2023]
In a study involving three patients with glioblastoma, 13C MR spectroscopic imaging using hyperpolarized pyruvate successfully detected increased lactate production in tumor regions prior to surgical resection, indicating altered metabolism in these aggressive tumors.
The imaging technique correlated well with histological findings, confirming the presence of WHO grade IV glioblastoma and suggesting that this method could help identify metabolic changes associated with tumor aggressiveness.
Preoperative imaging of glioblastoma patients using hyperpolarized 13C pyruvate: Potential role in clinical decision making.Chen, J., Patel, TR., Pinho, MC., et al.[2022]

References

Detecting response of rat C6 glioma tumors to radiotherapy using hyperpolarized [1- 13C]pyruvate and 13C magnetic resonance spectroscopic imaging. [2021]
Hyperpolarized [2-13C]pyruvate MR molecular imaging with whole brain coverage. [2023]
Preoperative imaging of glioblastoma patients using hyperpolarized 13C pyruvate: Potential role in clinical decision making. [2022]
Hyperpolarized Carbon-13 MRI in Breast Cancer. [2023]
Hyperpolarized Carbon 13 MRI: Clinical Applications and Future Directions in Oncology. [2023]
Pilot Study of Hyperpolarized 13C Metabolic Imaging in Pediatric Patients with Diffuse Intrinsic Pontine Glioma and Other CNS Cancers. [2022]
Metabolic imaging in the anesthetized rat brain using hyperpolarized [1-13C] pyruvate and [1-13C] ethyl pyruvate. [2021]
In Vivo Metabolic Imaging of [1-13 C]Pyruvate-d3 Hyperpolarized By Reversible Exchange With Parahydrogen. [2023]
Metabolic Imaging of the Human Brain with Hyperpolarized 13C Pyruvate Demonstrates 13C Lactate Production in Brain Tumor Patients. [2019]
10.United Statespubmed.ncbi.nlm.nih.gov
Imaging Glioblastoma Metabolism by Using Hyperpolarized [1-13C]Pyruvate Demonstrates Heterogeneity in Lactate Labeling: A Proof of Principle Study. [2022]
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